WATER Recall D-1031-2022
Description: Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06
WATER Recall D-1031-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1031-2022 |
| Event ID | 89646 |
| Brand | STERILE WATER |
| Generic Name | WATER |
| Manufacturer | WATER |
| Original Package? | 1 |
| Active Substance | WATER |
| Drug Route | INTRAVENOUS |
| Distribution | USA nationwide. |
| Quantity | unknown |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0338-0013 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 059QF0KO0R |
| Drug Application Number | NDA018632 |
| Structured Product Labeling (SPL ID) | 38e6f41f-36c5-47c9-857a-eaa2fc137eb3 |
| Structured Product Labeling (SPL Set ID) | 210dc9ab-d6ca-4552-ac19-1be17792d290 |
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